09.10.19
The Netherlands-based biotech Citryll and contract development and manufacturing organization (CDMO) Lonza have entered a partnership to develop and manufacture Citryll’s tACPA therapeutic antibody CIT-013. CIT-013 targets Neutrophil Extracellular Trap (NET) biology, and could offer new treatment options for a range of diseases where NETs play a role in disease pathology including autoimmune diseases like lupus, rheumatoid arthritis, vasculitis and others.
By targeting NET formation and NETs directly, CIT-013 does not broadly target inflammation or acquired immunity, but rather targets the source of autoantigens, proinflammatory as well as toxic NET components.
Scientific teams from the two companies have been working together to develop Citryll’s lead antibody candidate CIT-013. Using Lonza’s broad portfolio of in silico preclinical services to assess manufacturability and immunogenicity, Citryll further improved the quality and the potency of the product.
Lonza will carry out cell line construction as well as cGMP drug substance manufacturing at its Slough, UK site. Drug product manufacturing for Citryll’s clinical supply needs will be carried out at Lonza’s recently acquired facility in Stein, Switzerland. The two companies will also work together on the regulatory requirements to secure a successful CTA/IND filing. Citryll aims to start the CIT-013 clinical studies in two years.
“With our initial funding secured we’re confident going into the next phase of the development of CIT-013,” said Helmuth van Es, chief executive officer, Citryll. “Having access to Lonza’s expertise in manufacturing and regulatory pathways will help us move to the clinic as efficiently as possible, bringing new therapeutic options to those suffering from illnesses where NETs induce the pathology including autoimmune diseases such as lupus.”
Karen Fallen, head of mammalian and microbial development and manufacturing, Lonza, said, “Citryll is at an exciting time in their development program and we will be supporting them to help ensure they are fully prepared for a first in human clinical trial of their new therapy. Early-stage companies are an important part of our business and we have the tools and technologies to help de-risk their candidate. Ensuring solutions for the lifecycle of their product together with business models in sync with their funding all contribute to reducing the risks for growing companies.”
By targeting NET formation and NETs directly, CIT-013 does not broadly target inflammation or acquired immunity, but rather targets the source of autoantigens, proinflammatory as well as toxic NET components.
Scientific teams from the two companies have been working together to develop Citryll’s lead antibody candidate CIT-013. Using Lonza’s broad portfolio of in silico preclinical services to assess manufacturability and immunogenicity, Citryll further improved the quality and the potency of the product.
Lonza will carry out cell line construction as well as cGMP drug substance manufacturing at its Slough, UK site. Drug product manufacturing for Citryll’s clinical supply needs will be carried out at Lonza’s recently acquired facility in Stein, Switzerland. The two companies will also work together on the regulatory requirements to secure a successful CTA/IND filing. Citryll aims to start the CIT-013 clinical studies in two years.
“With our initial funding secured we’re confident going into the next phase of the development of CIT-013,” said Helmuth van Es, chief executive officer, Citryll. “Having access to Lonza’s expertise in manufacturing and regulatory pathways will help us move to the clinic as efficiently as possible, bringing new therapeutic options to those suffering from illnesses where NETs induce the pathology including autoimmune diseases such as lupus.”
Karen Fallen, head of mammalian and microbial development and manufacturing, Lonza, said, “Citryll is at an exciting time in their development program and we will be supporting them to help ensure they are fully prepared for a first in human clinical trial of their new therapy. Early-stage companies are an important part of our business and we have the tools and technologies to help de-risk their candidate. Ensuring solutions for the lifecycle of their product together with business models in sync with their funding all contribute to reducing the risks for growing companies.”
